(196 days)
The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:
- · STERRAD™ 100S Sterilization System
- · STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology - · STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology
STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
- · STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.
The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:
- . STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only). - . STERRAD NX™ Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD™ 100S Sterilization System
The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.
The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.
The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.
The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.
The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.
The provided document describes the acceptance criteria and the studies conducted for several sterilization process indicators and related devices (Chemical Indicator Strip, Chemical Indicator Tape, Biological Indicator, Biological Indicator Reader, and Process Challenge Device Vial). The studies aim to demonstrate the substantial equivalence of these devices to their legally marketed predicates, particularly with the inclusion of the new ULTRA GI Cycle.
Here's a breakdown of the requested information for each device where available:
1. STERRAD™ Chemical Indicator (CI) Strip (14100)
1. Table of acceptance criteria and reported device performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemical Indicator Functionality | The Chemical Indicator will not change color when not exposed to the cycle parameter indication. The Chemical Indicator will change color when exposed to cycle parameter indication. | Pass |
| Residual Biocompatibility | The residual hydrogen peroxide level shall be below the LOQ and exhibit mild toxicity or lower. | Pass |
| End Point / Post Processing Color Stability | The chemical indicator shall perform to the Type 1 requirements of ISO 11140-1:2014. | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
- Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective chemical reactions and physical changes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not applicable for chemical indicators.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
- Yes, the studies described are standalone performance tests of the chemical indicator strip itself.
7. Type of ground truth used:
- Objective physical/chemical change (color change due to hydrogen peroxide exposure) validated against ISO 11140-1:2014 Type 1 requirements.
8. Sample size for the training set:
- Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.
9. How the ground truth for the training set was established:
- Not applicable.
2. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)
1. Table of acceptance criteria and reported device performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Chemical Indicator Functionality | The Chemical Indicator will not change color when not exposed to the cycle parameter indication. The Chemical Indicator will change color when exposed to cycle parameter indication. | Pass |
| Residual Biocompatibility | The residual hydrogen peroxide level shall be below the LOQ and exhibit mild toxicity or lower. | Pass |
| End Point / Post Processing Color Stability | The chemical indicator shall perform to the Type 1 requirements of ISO 11140-1:2014. | Pass |
| Tape Adhesion Strength | The peel strength (adhesion-strength) must meet the acceptance criteria. | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
- Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective chemical reactions and physical changes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not applicable for chemical indicators.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
- Yes, the studies described are standalone performance tests of the chemical indicator tape itself.
7. Type of ground truth used:
- Objective physical/chemical change (color change due to hydrogen peroxide exposure) and physical properties (adhesion strength) validated against ISO 11140-1:2014 Type 1 requirements.
8. Sample size for the training set:
- Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.
9. How the ground truth for the training set was established:
- Not applicable.
3. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader (43210, 43210-30, 43220)
1. Table of acceptance criteria and reported device performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biological Indicator Performance | General trend of increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs negative for fluorescence and growth at full cycle. | Pass |
| Verification of Growth Inhibition of the Biological Indicator | All test samples (positive controls) show growth. All negative controls show no growth. | Pass |
| Chemical Indicator Functionality of Biological Indicator | Chemical Indicator will not change color when not exposed to the cycle parameter indication. Chemical Indicator will change color when exposed to cycle parameter indication. | Pass |
| Fluorescence Performance of Biological Indicator | BI fluorescence-positive for greater than 97.0% of all growth-positive BIs. | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
- Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable. Ground truth for biological indicators is based on microbiological growth/no growth and fluorescence detection, which are objective measures.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective microbiological and fluorescence readings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not applicable for biological indicators and their readers.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
- Yes, the studies described are for the standalone performance of the biological indicator and the reader. The reader's "algorithm" interprets the fluorescence, but it's not described as an AI/ML system requiring typical training/test sets.
7. Type of ground truth used:
- Microbiological growth (absence or presence of Geobacillus stearothermophilus ATCC 7953) and fluorescence detection, which correlates to enzymatic activity of the organism.
8. Sample size for the training set:
- Not applicable. While the reader processes data, it's not described as an AI/ML system with a separate training set.
9. How the ground truth for the training set was established:
- Not applicable.
4. ULTRA GI™ Process Challenge Device (PCD) Vial (43400)
1. Table of acceptance criteria and reported device performance:
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Hydrogen Peroxide Dose-Response and Sterilization Verification | The general trend is an increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs are negative for fluorescence and growth at full cycle. | Pass |
| Performance Qualification | The STERRAD VELOCITY BI/PCD fluorescence readout is qualified for performance in frequent monitoring and periodic testing indication. | Pass |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
- Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable. Ground truth for PCDs is based on the resistance they provide to the sterilization process, measured using biological indicator growth/no growth and fluorescence detection.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective microbiological and fluorescence readings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This is not applicable for PCDs.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done:
- Yes, the studies described are for the standalone performance of the PCD vial in conjunction with the biological indicator and reader.
7. Type of ground truth used:
- Microbiological growth (absence or presence of Geobacillus stearothermophilus) and fluorescence detection, demonstrating the designed resistance to the sterilization process.
8. Sample size for the training set:
- Not applicable.
9. How the ground truth for the training set was established:
- Not applicable.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).